Bioequivalence and Bioavailability Forum

Good Evening (Guten Abend): We have completed a parallel group PK design of a drug formulation (test versus reference). So there is only 1 period and 2 formulations evaluated in 2 groups of 12 subjects.

I have the program WinNonlin and another program that does ANOVA (NCSS) To use the data and make a sample size estimate for a future parallel group study. I believe I need to have the inter-subject variance of the PK paramater.

I use the LN values of the PK paramater. So I think a one way ANOVA is appropriate and what is the correct name of the inter subject variance paramater given by the ANOVA output? I am on the LN scale so I think I take the square root of the intersubject variance paramater and multiply by 100 to get the CV as percentage.

Please can I be advised of the terminology and if I am doing the correct calculation.

Best Regards,

Angus